AMS 700 MS Pump with and without InhibiZone — Class II medical device recall Z-0427-2021
Ongoing recall by Boston Scientific Corporation, reported 2020-11-18, distributed nationwide. The recalling firm has observed an increase in complaints of problems encountered during the initial activatio
| Recall number | Z-0427-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-09-24 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EC, EE, ES, FI, FR, GB, GR, GT, HK, HR, IE, IL, IN, IR, IT, KR, LB, MT, MX, MY, NL, NO, NZ, PA, PL, PT, QA, RO, RS, SA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 24,064 |
Product
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Reason for recall
The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0427-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.